WHFM/MS-DIARY: An Integrated Wearable Hot Flash Monitor and Portable Electronic D

描述(由申请人提供)：WHFM/MS-DIARY：一种用于更年期症状的集成可穿戴式热闪光监视器和便携式电子日记：摘要：大多数美国妇女在更年期过渡期间将经历潮热和盗汗。这些血管舒缩症状是更年期妇女寻求治疗的主要原因。随着妇女健康倡议的最新结果，许多妇女正在寻找非激素方法来管理她们的血管舒缩和其他与更年期相关的症状。这导致人们更加重视研究针对这些症状的补充和替代治疗方法。然而，这一领域目前受到缺乏用于门诊条件下的临床研究的仪器和设备的限制，这些仪器和设备既能捕捉到更年期症状的客观和主观测量，也能用于临床研究。胸骨皮肤电导设备非常适合在门诊环境中使用，以捕获潮热的频率数据。梅蒂斯设计公司目前正在开发一种可穿戴的胸骨皮肤电导设备，用于动态热闪监测。然而，这种设备和其他设备一样，无法捕捉潮热的所有方面，如强度和对日常生活的干扰。此外，更年期的其他症状领域，如情感性症状、躯体症状和泌尿生殖系统症状仍未被捕获。在早期关于更年期的研究中使用了各种问卷和日记，但得到验证的并不多。此外，通过计算机辅助自访用于更年期临床研究的自动数据收集的数据也很少。改进的仪器和设备收集关于更年期更广泛症状的自我报告数据，将对未来CAM疗法的临床试验非常有益。这项应用的目标是开发一种集成设备，使用可穿戴的胸骨皮肤电导设备记录潮热的客观测量，并收集和存储有关更年期症状的自我报告数据。梅蒂斯设计公司将开发用于自我报告更年期症状的集成胸骨皮肤电导装置和电子日记。该设备将在维克森林大学医学院进行临床验证。可穿戴式潮热监测仪(WHFM)记录皮肤电导，电子日记记录更年期症状(MS日记)。集成系统称为WHFM/MS-DIARY。将开发捕捉与更年期相关症状的所有维度的问题。将开发一种记录更年期症状的电子日记。电子日记将与WHFM紧密结合，使用时间戳。WHFM/MS日记将在流动条件下进行试点测试。将确定进一步完善和改进这些系统的后续步骤。将探索规模经济，为大规模临床试验生产大量设备。WHFM/MS-Diary：用于更年期症状的集成可穿戴式潮热监视器和便携式电子日记：叙述：大多数美国妇女在更年期过渡期间会出现潮热和盗汗。这些血管舒缩症状是更年期妇女寻求治疗的主要原因。随着妇女健康倡议的最新结果，许多妇女正在寻找非激素方法来管理她们的血管舒缩和其他与更年期相关的症状。这导致人们更加重视研究针对这些症状的补充和替代治疗方法。然而，这一领域目前受到缺乏用于门诊条件下的临床研究的仪器和设备的限制，这些仪器和设备既能捕捉到更年期症状的客观和主观测量，也能用于临床研究。胸骨皮肤电导设备非常适合在门诊环境中使用，以捕获潮热的频率数据。梅蒂斯设计公司目前正在开发一种可穿戴的胸骨皮肤电导设备，用于动态热闪监测。然而，这种设备和其他设备一样，无法捕捉潮热的所有方面，如强度和对日常生活的干扰。此外，更年期的其他症状领域，如情感性症状、躯体症状和泌尿生殖系统症状仍未被捕获。在早期关于更年期的研究中使用了各种问卷和日记，但得到验证的并不多。此外，通过计算机辅助自访用于更年期临床研究的自动数据收集的数据也很少。改进的仪器和设备收集关于更年期更广泛症状的自我报告数据，将对未来CAM疗法的临床试验非常有益。这项应用的目标是开发一种集成设备，使用可穿戴的胸骨皮肤电导设备记录潮热的客观测量，并收集和存储有关更年期症状的自我报告数据。梅蒂斯设计公司将开发用于自我报告更年期症状的集成胸骨皮肤电导装置和电子日记。该设备将在维克森林大学医学院进行临床验证。可穿戴式潮热监测仪(WHFM)记录皮肤电导，电子日记记录更年期症状(MS日记)。集成系统称为WHFM/MS-DIARY。将开发捕捉与更年期相关症状的所有维度的问题。将开发一种记录更年期症状的电子日记。电子日记将与WHFM紧密结合，使用时间戳。WHFM/MS日记将在流动条件下进行试点测试。将确定进一步完善和改进这些系统的后续步骤。将探索规模经济，为大规模临床试验生产大量设备。

DESCRIPTION (provided by applicant): WHFM/MS-DIARY: An Integrated Wearable Hot Flash Monitor and Portable Electronic Diary for Menopausal Symptomatology: Summary: The majority of American women transitioning through the menopause will experience hot flashes and night sweats. These vasomotor symptoms are the leading cause of treatment-seeking among menopausal women. With recent results of the Women's Health Initiative, many women are looking for non-hormonal ways to manage their vasomotor and other menopause related symptoms. This has resulted in increased attention to studying complementary and alternative treatments for these symptoms. However, the field is currently limited by lack of instruments and devices that capture both objective and subjective measures of menopausal symptoms for use in clinical studies under ambulatory conditions. Sternal skin conductance devices are well suited for use in ambulatory settings to capture frequency data on hot flashes. Metis Design Corporation is currently developing a wearable sternal skin conductance device for ambulatory hot flash monitoring. This device, as well as others, however, are not able to capture all dimensions of hot flashes, such as intensity and interference with daily life. Moreover, other symptom domains of menopause, such as affective, somatic and urogenital symptoms remain uncaptured. Various questionnaires and diaries have been used in earlier studies of menopause, but not many have been validated. Further, there is a paucity of data on automated data collection used in clinical studies of menopause through computer assisted self interviews. Improved instruments and devices that collect self reported data on the broader symptoms of menopause would be very beneficial for future clinical trials of CAM therapies. The goal of this application is to develop an integrated device that records objective measures of hot flashes using a wearable sternal skin conductance device and collects and stores self-reported data on menopausal symptoms. The integrated sternal skin conductance device and electronic diary for self-reported menopausal symptoms will be developed by Metis Design Corporation. The device will be clinically validated at Wake Forest University School of Medicine. A wearable hot flash monitor (WHFM) records skin conductance and an electronic diary records menopausal symptomatologies (MS-DIARY). The integrated system is referred to as WHFM/MS-DIARY. Questions that capture all dimensions of symptoms associated with menopause will be developed. An electronic dairy to record menopausal symptomatology will be developed. The electronic diary will be integrated tightly with WHFM using time stamping. The WHFM/MS-DIARY will be pilot tested under ambulatory conditions. Subsequent steps to refine and improve these systems will be determined. Economies of scale will be explored for producing large number of devices for large scale clinical trials. WHFM/MS-DIARY: An Integrated Wearable Hot Flash Monitor and Portable Electronic Diary for Menopausal Symptomatology: Narrative: The majority of American women transitioning through the menopause will experience hot flashes and night sweats. These vasomotor symptoms are the leading cause of treatment-seeking among menopausal women. With recent results of the Women's Health Initiative, many women are looking for non-hormonal ways to manage their vasomotor and other menopause related symptoms. This has resulted in increased attention to studying complementary and alternative treatments for these symptoms. However, the field is currently limited by lack of instruments and devices that capture both objective and subjective measures of menopausal symptoms for use in clinical studies under ambulatory conditions. Sternal skin conductance devices are well suited for use in ambulatory settings to capture frequency data on hot flashes. Metis Design Corporation is currently developing a wearable sternal skin conductance device for ambulatory hot flash monitoring. This device, as well as others, however, are not able to capture all dimensions of hot flashes, such as intensity and interference with daily life. Moreover, other symptom domains of menopause, such as affective, somatic and urogenital symptoms remain uncaptured. Various questionnaires and diaries have been used in earlier studies of menopause, but not many have been validated. Further, there is a paucity of data on automated data collection used in clinical studies of menopause through computer assisted self interviews. Improved instruments and devices that collect self reported data on the broader symptoms of menopause would be very beneficial for future clinical trials of CAM therapies. The goal of this application is to develop an integrated device that records objective measures of hot flashes using a wearable sternal skin conductance device and collects and stores self-reported data on menopausal symptoms. The integrated sternal skin conductance device and electronic diary for self-reported menopausal symptoms will be developed by Metis Design Corporation. The device will be clinically validated at Wake Forest University School of Medicine. A wearable hot flash monitor (WHFM) records skin conductance and an electronic diary records menopausal symptomatologies (MS-DIARY). The integrated system is referred to as WHFM/MS-DIARY. Questions that capture all dimensions of symptoms associated with menopause will be developed. An electronic dairy to record menopausal symptomatology will be developed. The electronic diary will be integrated tightly with WHFM using time stamping. The WHFM/MS-DIARY will be pilot tested under ambulatory conditions. Subsequent steps to refine and improve these systems will be determined. Economies of scale will be explored for producing large number of devices for large scale clinical trials.